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United States · US · US:59630-266_64c35e73-1daa-4a82-a3c2-a737dec6eeae

Fetroja

Orange BookUNIISPLATC J01DI

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerShionogi Inc.
CountryUS (United States)
ATC codeJ01DI
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5963026610
    10 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01)

Annotations

UNII (FDA Substance ID)
TTP8LBP45D
CEFIDEROCOL SULFATE TOSYLATE
RxCUI 2265863
Orange Book
N209445
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "TTP8LBP45D",
    "rxcui": "2265863",
    "inchikey": "QNMVZYPDWLKAJC-RXVBEKIDSA-N",
    "display_name": "CEFIDEROCOL SULFATE TOSYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "75c0c785-38e0-4049-a6fb-b77581f5b35c": {
      "match": "brand_token",
      "title": "FETROJA (CEFIDEROCOL SULFATE TOSYLATE) INJECTION, POWDER, FOR SOLUTION [SHIONOGI INC.]",
      "spl_version": "11",
      "published_date": "2026-04-30"
    }
  },
  "productid": "59630-266_64c35e73-1daa-4a82-a3c2-a737dec6eeae",
  "productndc": "59630-266",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "209445",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Nov 14, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFIDEROCOL SULFATE TOSYLATE",
  "proprietary_name": "Fetroja",
  "active_ingred_unit": "g/10mL",
  "application_number": "NDA209445",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cefiderocol sulfate tosylate",
  "start_marketing_date": "20200131",
  "active_numerator_strength": "1"
}

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